NCT06611059

Brief Summary

This is a two steps observational study In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described. Once the accuracy of the guide is acceptable, we will implant the glenosphere of future patients using the PSG guide following the same engineering design process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

December 19, 2023

Last Update Submit

November 4, 2024

Conditions

Proximal Humeral Fracture

Keywords

reverse shoulder arthroplastypatient specific guide3D

Outcome Measures

Primary Outcomes (3)

  • Difference in glenoid center

    Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn

    months

  • Glenoid version deviation (α)

    Glenoid version deviation (α): defined as the angle between the real trajectory of the drilling and the scapular anatomical plane, projected about the axis of neutral inclination (defined as that which goes from the center of the glenoid to the trigonum spinae).

    months

  • Glenoid inclination deviation (β)

    Glenoid inclination deviation (β): defined as the angle between the actual milling path and the plane of the neutral tilt axis, projected on the SP axis

    months

Study Arms (1)

in-hospital designed patient specific guide

Device: PSG

Interventions

PSGDEVICE

Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately

Also known as: Patient Specific Guides
in-hospital designed patient specific guide

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: * Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty * Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

You may qualify if:

  • Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
  • Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

You may not qualify if:

  • Previous surgeries on the proximal humerus or glenoid
  • No desire to participate in the study
  • Lack of ability to accept the study (tutored patients)
  • Open fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (11)

  • Gauci MO. Patient-specific guides in orthopedic surgery. Orthop Traumatol Surg Res. 2022 Feb;108(1S):103154. doi: 10.1016/j.otsr.2021.103154. Epub 2021 Nov 24.

    PMID: 34838754BACKGROUND

  • Gonzalez JF, Alami GB, Baque F, Walch G, Boileau P. Complications of unconstrained shoulder prostheses. J Shoulder Elbow Surg. 2011 Jun;20(4):666-82. doi: 10.1016/j.jse.2010.11.017. Epub 2011 Mar 21. No abstract available.

    PMID: 21419661BACKGROUND

  • Jacquot A, Gauci MO, Chaoui J, Baba M, Deransart P, Boileau P, Mole D, Walch G. Proper benefit of a three dimensional pre-operative planning software for glenoid component positioning in total shoulder arthroplasty. Int Orthop. 2018 Dec;42(12):2897-2906. doi: 10.1007/s00264-018-4037-1. Epub 2018 Jul 2.

    PMID: 29968136BACKGROUND

  • Berhouet J, Gulotta LV, Dines DM, Craig E, Warren RF, Choi D, Chen X, Kontaxis A. Preoperative planning for accurate glenoid component positioning in reverse shoulder arthroplasty. Orthop Traumatol Surg Res. 2017 May;103(3):407-413. doi: 10.1016/j.otsr.2016.12.019. Epub 2017 Feb 24.

    PMID: 28238965BACKGROUND

  • Gauci MO, Boileau P, Baba M, Chaoui J, Walch G. Patient-specific glenoid guides provide accuracy and reproducibility in total shoulder arthroplasty. Bone Joint J. 2016 Aug;98-B(8):1080-5. doi: 10.1302/0301-620X.98B8.37257.

    PMID: 27482021BACKGROUND

  • Iannotti JP, Walker K, Rodriguez E, Patterson TE, Jun BJ, Ricchetti ET. Accuracy of 3-Dimensional Planning, Implant Templating, and Patient-Specific Instrumentation in Anatomic Total Shoulder Arthroplasty. J Bone Joint Surg Am. 2019 Mar 6;101(5):446-457. doi: 10.2106/JBJS.17.01614.

    PMID: 30845039BACKGROUND

  • Levy JC, Everding NG, Frankle MA, Keppler LJ. Accuracy of patient-specific guided glenoid baseplate positioning for reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Oct;23(10):1563-7. doi: 10.1016/j.jse.2014.01.051. Epub 2014 Apr 13.

    PMID: 24739791BACKGROUND

  • Cabarcas BC, Cvetanovich GL, Espinoza-Orias AA, Inoue N, Gowd AK, Bernardoni E, Verma NN. Novel 3-dimensionally printed patient-specific guide improves accuracy compared with standard total shoulder arthroplasty guide: a cadaveric study. JSES Open Access. 2019 Jun 15;3(2):83-92. doi: 10.1016/j.jses.2019.04.001. eCollection 2019 Jul.

    PMID: 31334434BACKGROUND

  • Dallalana RJ, McMahon RA, East B, Geraghty L. Accuracy of patient-specific instrumentation in anatomic and reverse total shoulder arthroplasty. Int J Shoulder Surg. 2016 Apr-Jun;10(2):59-66. doi: 10.4103/0973-6042.180717.

    PMID: 27186057BACKGROUND

  • Cabarcas BC, Cvetanovich GL, Gowd AK, Liu JN, Manderle BJ, Verma NN. Accuracy of patient-specific instrumentation in shoulder arthroplasty: a systematic review and meta-analysis. JSES Open Access. 2019 Sep 18;3(3):117-129. doi: 10.1016/j.jses.2019.07.002. eCollection 2019 Oct.

    PMID: 31709351BACKGROUND

  • Villatte G, Muller AS, Pereira B, Mulliez A, Reilly P, Emery R. Use of Patient-Specific Instrumentation (PSI) for glenoid component positioning in shoulder arthroplasty. A systematic review and meta-analysis. PLoS One. 2018 Aug 22;13(8):e0201759. doi: 10.1371/journal.pone.0201759. eCollection 2018.

    PMID: 30133482BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • A. Millan

    Orthopedic and Trauma Dept. / Trauma Unit

    PRINCIPAL INVESTIGATOR

  • A. Toro

    Orthopedic and Trauma Dept. / Trauma Unit

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

September 24, 2024

Study Start

April 1, 2023

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Locations

ES(1)